Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 188
- 试验地点
- 4
- 主要终点
- rate of estimated GFR decline
研究概览
简要总结
Control of blood pressure (BP) is the first thing to do in the management of chronic kidney disease (CKD). Although guidelines suggest the optimal blood pressure level, it is hard to assess BP correctly during the office visit. Often there is a discrepancy between office BP and out-of-office BP, including home BP and ambulatory BP. Recent study reported that as many as 34% of Korean CKD patients had masked hypertension, which means high BP by ambulatory BP monitoring but normal BP by conventional office BP measurement.
This study aims to evaluate the effect of ambulatory BP-guided BP management on the clinical outcome of CKD, compared to the conventional management using office BP.
详细描述
We hypothesized that management of blood pressure using ambulatory BP monitoring would obtain more optimal BP control and thereby would influence positively on renal progression and CV outcomes.
In detail, when the eligibility criteria is met, all the subjects will undergo both ambulatory BP and office BP measurement at baseline.
After randomization, ARB (fimasartan) will be administered to drug-naive subjects or will replace the other RAS blockers in subjects with current uses. Dosing of fimasartan will be adjusted or additional drugs of other classes will be added sequentially over 3 months (titration phase).
At 3 months, ABPM will be performed in ABPM group to evaluate the adequacy of blood pressure control and dosing will be adjusted according to the ABPM results (target BP: daytime BP < 135/85 mm Hg). This adjustment will be assessed at 6 months by ABPM once again.
For subjects in office BP group, conventional care will be provided according to current guidelines (target BP < 140/90 mm Hg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Office BP > 130/80 mm Hg, irrespective of anti-hypertensive medication
- •CKD stages 3-4 (or estimated GFR 15-59 ml/min per 1.73 m2)
- •Random urine albumin-to-creatinine ratio > 300 mg/g or protein-to-creatinine ration > 300 mg/g or dipstick albumin > 1+, in case of estimated GFR 45-59 ml/min per 1.73 m2
排除标准
- •Systolic BP > 180 mm Hg or diastolic BP > 110 mm Hg
- •Malignant hypertension
- •Resistant hypertension (using more than three kind of anti-hypertensive drugs other than diuretics)
- •Uncontrolled DM (Hb A1c > 10.0% within 3 months of eligibility assessment)
- •Use of immunosuppressive agents within 1 months or anticipated
- •Atrial fibrillation or flutter
- •Contraindication to renin-angiotensin system blockers (hypersensitivity, bilateral renal artery stenosis, single kidney, etc.)
- •Pregnancy
- •Kidney recipients
- •Participating other clinical trials, except observational studies
研究组 & 干预措施
ABPM group
Ambulatory blood pressure monitoring (ABPM) performed at 3, 6 months after randomization; adjusting drugs/doses based on ABPM results.
Target BP: daytime ABP < 135/85 mm Hg according to British NICE clinical guideline 127.
干预措施: Ambulatory blood pressure monitoring (ABPM) (Device)
Office BP group
Conventional BP management using office BP according to KDIGO guideline on BP management.
Target BP: <140/90 mm Hg.
结局指标
主要结局
rate of estimated GFR decline
时间窗: 18 months
annual decline of eGFR over 18 months
次要结局
- All-cause mortality(18 months)
- Renal events(18 months)
- CV events(18 months)
- Albuminuria(18 months)
研究者
Kook-Hwan Oh
Associate professor, Division of Nephrology, Department of Internal Medicine
Seoul National University Hospital